High Flow Nasal Cannula Versus Non-invasive Ventilation in Prevention of Escalation to Invasive Mechanical Ventilation in Patients With Acute Hypoxemic Respiratory Failure

• ClinicalTrials.gov Identifier: NCT03788304
• Recruitment Status: Recruiting
• First Posted: December 27, 2018
• Last Update Posted: October 21, 2019
• Sponsor: Assiut University
• Information provided by (Responsible Party): Entsar Hsanen Mohamed, Assiut University

Study Description

Brief Summary:

Oxygen therapy is first-line treatment in the management of acute respiratory failure (ARF). Different oxygen devices have become available over recent decades, such as low-flow systems (nasal cannula, simple facemask, non-rebreathing reservoir mask) and high-flow systems (Venturi mask) . Since the 90's, non-invasive ventilation (NIV) has been largely used with strong level of evidence in cardiogenic pulmonary edema and chronic obstructive pulmonary disease (COPD) exacerbation. NIV improves gas exchange and reduces inspiratory effort through positive pressure. However, good tolerance to NIV is sometimes difficult to achieve due to frequent leaks around the mask, possibly leading to patient-ventilator asynchrony and even to intubation . High-flow nasal oxygen therapy (HFNO) is an innovative high-flow system that allows for delivering up to 60 liters\ min of heated and fully humidified gas with a FIO2 ranging between 21% and 100% . It is a new method of respiratory support in adults that has been used in neonatal ARF for some years. The reason this study is necessary is because, even though NIV has been demonstrated to prevent endotracheal intubation (and its associated complications) in a broad range of ARF patients, HFNC has been proposed to have the same effect as NIV while being easier tolerated, more physiological , allowing patients to continue to talk, eat and drink through mouth while on HFNC

Condition or disease	Intervention/treatment	Phase
Respiratory Failure	Device: non-invasive ventilation; Device: high flow nasal cannula	Not Applicable

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Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: patients with will be randomly enrolled to either non invasive group or HFNC group and improvement and patient satisfaction will be assessed
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Neither the participant , care provider , the investigator nor the outcome assessor will select patients in both groups , see results of other patients till the end of the study or informed by literature opinion in this intervention
• Primary Purpose: Treatment
• Official Title: High Flow Nasal Cannula Versus Non-invasive Ventilation in Prevention of Escalation to Invasive Mechanical Ventilation in Patients With Acute Hypoxemic Respiratory Failure
• Actual Study Start Date: May 1, 2019
• Estimated Primary Completion Date: April 30, 2020
• Estimated Study Completion Date: December 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Non invasive ventilation; Respiratory assistance is provided by a NIV either Puritan Bennet 840 , Engström Carestation or Hamilton-G5 , will be used for conventional non-invasive ventilation via an oronasal mask. Settings will be adjusted based on the clinical assessment of the respiratory therapist . Initial setting includes: -; Positive End Expiratory Pressure (PEEP): 5 cmH2O.; Pressure support (PS): 12-20 cmH2O.; FiO2 will be adjusted to achieve a SpO2 at least 95%	Device: non-invasive ventilation; conventional NIV
Experimental: High flow nasal cannula; High flow nasal cannula consists of an apparatus that allows adjustable FiO2 from 21 to 100% and delivers a modified gas flow up to 60 l/ min . will be set with: -; Temperature at 37°C or 34°C; Flow rate 30: 50 L/min.; FiO2 will be adjusted to achieve a SpO2 at least 95%	Device: high flow nasal cannula; HFNC ventilation

Outcome Measures

Primary Outcome Measures :

1. Endotracheal intubation rate. [ Time Frame: one week ]
   needs escalation to invasive mechanical ventilation

Secondary Outcome Measures :

1. In hospital mortality. [ Time Frame: one week ]
   death
2. length of hospital stay [ Time Frame: one week ]
   hospital coast
3. duration of ICU stay [ Time Frame: one week ]
   icu occupancy
4. duration of intervention [ Time Frame: one week ]
   need ventilatory support
5. development of complications [ Time Frame: one week ]
   due to devices

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Participants admitted to the RICU with acute hypoxemic respiratory failure requiring NIV support with the following criteria:

  1. RR> 25 breath/minute
  2. Use of accessory muscles of respiration, paradoxical breathing, thoracoabdominal asynchrony.
  3. Hypoxemia evidenced by PaO2 / FiO2 ratio <300

Exclusion Criteria:

Patients who have any of the following:

I. Indication for emergency endotracheal intubation. II. HR <50 beat\minute with decreased level of consciousness III. Persistent hemodynamic instability with

• Systolic blood pressure <90 mmHg after infusing a bolus of crystalloid solution at a dose of 30 ml / kg
• life-threatening arrhythmia. IV. Undrained pneumothorax or Pneumothorax with persistent air leak. V. Extensive facial trauma or burn VI. Refusal to participate. VII. Usual long-term treatment with NIV for chronic disease VIII. Altered mental status with decreased consciousness and/or evidence of inability to understand .

IX. Tracheotomy or other upper airway disorders X. Active upper gastrointestinal bleeding

Contacts and Locations

Contacts

Contact: Entsar H mohamed, MD; +201019968106; dr.entsar_hsanen@yahoo.com

Contact: Gamal M Rabie, professor; +201155213224; Gamalagmy135@gmail.com

Locations

Egypt

Assiut University hospital; Recruiting

Assiut, Egypt, assiut University 71515

Contact: Entsar H mohamed, master 01019968106 dr.entsar_hsanen@yahoo.com

Contact: Gamal M Rabie, MD 01155213224 Gamalagmy135@gmail.com

Sponsors and Collaborators

Assiut University

Investigators

• Principal Investigator: Mohamed F Adam, lecturer; Assiut University
• Principal Investigator: Manal A El-Khawaga, lecturer; Assiut University

More Information

Publications:

1-Renda, T., Corrado, A., Iskandar, G., et al. High-flow nasal oxygen therapy in intensive care and anaesthesia . British journal of anaesthesia 2018 , 120(1), 18-27 2-Kallstrom TJ. AARC clinical practice guideline: oxygen therapy for adults in the acute care facility: 2002 revision and update. Respir Care 2002; 47: 717-20. 3-O'Driscoll BR, Howard LS, Davison AG, on behalf of the British Thoracic Society. BTS guideline for emergency oxygen use in adult patients. Thorax 2008; 63: 1-68. 4-Sim MA, Dean P, Kinsella J, et al. Performance of oxygen delivery devices when the breathing pattern of respiratory failure is simulated. Anaesthesia 2008; 63: 938-40 5-Nishimura, M. High-flow nasal cannula oxygen therapy in adults: physiological benefits, indication, clinical benefits, and adverse effects. Respiratory Care 2016, 61(4), 529-541.

• Responsible Party: Entsar Hsanen Mohamed, principle investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT03788304 History of Changes
• Other Study ID Numbers: High flow nasal cannula
• First Posted: December 27, 2018
• Last Update Posted: October 21, 2019
• Last Verified: October 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases